Clinical Evaluation of TrueVision System: LRI and Capsulorhexis Templates

Phase 1

Completed

• Conditions: Subjects Undergoing Cataract Surgery and Insertion of IOL
• Interventions: Device: TrueVision 3D Visualization and Guidance System for MicroSurgery

• Registration Number: NCT01123343
• Lead Sponsor: TrueVision Systems, Inc

Brief Summary

To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery. Device images, safety results and surgeon questionnaire will demonstrate that the TrueVision system provides clear images to assist surgeons during LRI or capsulorhexis procedures.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-05-12
• Study First Submitted QC: 2010-05-12
• Study First Posted: 2010-05-14
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Healthy eye with no previous ocular surgery
• Natural lens for which phacoemulsification extraction and posterior IOL implantation is planned
• Clear intraocular media other than cataract
• Potential visual acuity 20/30 or better
• Able to comply with preop and postop examination procedures
• Signed and dated informed consent

Exclusion Criteria

• Keratometric astigmatism > 2.5 diopters
• Corneal pathology potentially affecting topography including corneal degeneration
• Irregular astigmatism
• Macular degeneration or any other macular disease which reduces potential acuity
• Previous corneal surgery (including LASIK, radial keratotomy, penetrating keratoplasty, etc)
• Use of systemic or ocular medications that affects vision
• Acute or chronic systemic or ocular disease or illness that would increase risk or confound study results
• Use of Flomax or any other medication which negatively impacts surgical outcomes
• History of ocular trauma or ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LRI Templates	TrueVision 3D Visualization and Guidance System for MicroSurgery	To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for LRI.
Capsulorhexis Templates	TrueVision 3D Visualization and Guidance System for MicroSurgery	To evaluate the ability of the TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM FOR MICROSURGERY to provide the ophthalmic surgeon appropriate alignment, orientation and sizing information during cataract or refractive lens exchange surgery compared to the current standard of care (manual markings or heuristic techniques) for Capsulorhexis.

Primary Outcome Measures

Name	Time	Method
Demonstrate that the TrueVision system provides clear images to assist during LRI or capsulorhexis procedures	one month

Trial Locations

Locations (1)

Drs. Fine, Hoffman and Packer; 🇺🇸 Eugene, Oregon, United States